Pre-Surgery Radiation Therapy for Mesothelioma
(SMARTER Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJohn Cho, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study aims to find the maximum tolerated dose level for malignant pleural mesothelioma patients receiving background radiation + boost radiation, and surgery. Boost radiation is an experimental form of radiation that involves targeting non-uniform high doses of radiation to bulky pleural masses. We hypothesize the immunologic abscopal effect is an important component in controlling disease, and may be stimulated with highly hypofractionated doses. Doses will increase with every three patients who will be enrolled in the study until the background radiation reaches 1800 cGy or the maximum tolerated dose, whichever is lower.

Research Team

John Cho, MD

Principal Investigator

Princess Margaret Hospital, Canada

Eligibility Criteria

Adults over 18 with early-stage malignant pleural mesothelioma, good lung function, and performance status. They must be new diagnoses without prior thoracic radiation or chemotherapy for this cancer or others within the last 3 years (except certain non-invasive cancers). Pregnant women are excluded.

Inclusion Criteria

My lung function is good enough that I can't have radiation therapy.

I can take care of myself and am up and about more than half of my waking hours.

I am eligible for treatment that combines different methods.

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Exclusion Criteria

I have had radiation therapy to the chest area before.

I have had cancer before, but it was either non-melanoma skin cancer, non-invasive breast cancer, prostate cancer treated to cure, or any cancer treated over 3 years ago without recurrence.

I need help with my daily activities or am unable to do them.

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Treatment Details

Interventions

Background and Boost RT (Radiation)
Surgery for Mesothelioma (Procedure)

Trial OverviewThe study is testing how much radiation can be safely given to mesothelioma patients before surgery. It involves increasing doses of background plus boost radiation until reaching a maximum safe level or a set dose limit.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: RadiationExperimental Treatment1 Intervention

This study involves a 3+3 design. The starting cohort (n=3) will receive a neoadjuvant Background dose to the affected hemithorax (starting at 0 cGy) as well as concomitant Boost dose (of at least 2100 cGy) to a part of the gross tumour volume (GTV). The radiation will be delivered over 3 alternate days over 5-7 calendar days followed by macroscopically complete extensive pleural resection (either extra-pleural pneumonectomy or extended pleurectomy decortication, at the surgeon's discretion) after 7 to 14 days. If no dose limiting toxicities (DLTs) seen, then the Background RT dose will be increased by 600 cGy (up to 1800 cGy) and the cohort (n=3) for the next dose level will be accrued. If only 1 DLT seen, then an additional 3 patients will be treated on this dose level. If 2 or more DLTs seen at any given dose level, then the previous dose level will be defined as the maximum tolerated dose (MTD). Patients will be stratified by type of resection.